Compositions and methods are provided for inhibiting microbial infections associated with the use of sanitary products, such as diapers, bandages, sanitary napkins, tampons and the like. The invention provides a sanitary product containing an absorbent structure and an effective amount of a viable non-pathogenic lactic-acid bacteria, such as Bacillus coagulans, or an extracellular product thereof, useful for inhibiting growth of parasites and pathogens on the epithelial tissue in contact with the sanitary product during use of the product. Also provided is enhancing biodegradation of sanitary products after use and disposal.

This invention relates to systems and methods to inhibit microbial infections and to promote epithelial probiosis when using sanitary health care products such as disposable diapers and other sanitary products. In particular, the invention describes use of probiotic lactic acid bacteria in combination with sanitary health care products to inhibit microbial infections, promote dermal probiosis, and enhance biodegradatability of disposed sanitary products.
Sanitary products are widely used in various formats for personal hygiene and medical necessity, and include sanitary napkins, diapers, incontinence guards, wound dressings and the like. By their use, a local tissue environment is produced which promotes growth of microbial pathogens, local infections, irritation, rashes, and related problems.
In addition, disposal of used sanitary products is a major environmental and health care concern. The volume of material and the type of material present in the used sanitary product, due to its absorbent character and purpose of collecting body fluids and waste materials, provides a biological and environmental hazard in disposal of used sanitary products. There is a great need for improvements in biodegradation of used sanitary products: degradation of both, the product itself and the waste product it contains.
The present invention uses a bacterium that is probiotic and heterotrophic to resolve both of the above problems: to inhibit microbial infections associated with use of sanitary products, and to promote biodegradation of the sanitary product after use.
Probiotic agents are organisms that confer a benefit when they grow in a particular environment, often by inhibiting the growth of other microbial organisms in the same environment. Examples of probiotics include bacteria and bacteriophages which can grow and displace or destroy pathogens and provide other benefits to the host organism (Salminen et al, Antonie Van Leeuwenhoek, 70 (2-4): 347-358, 1996; Elmer et al, JAMA, 275:870-876, 1996; Rafter, Scand. J. Gastroenterol., 30:497-502, 1995; Perdigon et al, J. Dairy Sci., 78:1597-1606, 1995; Gandi, Townsend Lett. Doctors and Patients, pp.108-110, Jan. 1994; Lidbeck et al, Eur. J. Cancer Prev. 1:341-353, 1992).
The nutritional use of probiotic bacteria, especially Lactobacillus and Bifidobacterium strains, that colonize the gut has been previously disclosed (Winberg et al, Pediatr. Nephrol. 7:509-514, 1993; Malin et al, Ann. Nutr. Metab. 40:137-145, 1996; and U.S. Pat. No. 5,176,911).
Lactic acid producing bacteria (e.g., Bacillus, Lactobacillus and Streptococcus species) have been used as food additives and there have been some claims that they provide nutritional and therapeutic value (Gorbach, Ann. Med. 22:37-41, 1990; Reid et al, Clin. Microbiol. Rev., 3:335-344, 1990).
Heterotrophic bacteria play an important role in the biodegradation of animal waste and many natural and synthetic polymers. Bacterial strains including Bacillus, Pseudomonas, Arthrobacter, Achromobacter, Micrococcus and Rhodococcus have been shown to participate in the breakdown of waste products, cellulose materials, petroleum hydrocarbons and their associated products, such as plastics, synthetic rubbers and other synthetic materials.
Bacillus coagulans is a non-pathogenic gram positive spore-forming bacteria that produces L(+) lactic acid (dextrorotatory) in homofermentation conditions. It has been isolated from natural sources, such as heat-treated soil samples inoculated into nutrient medium (Bergey""s Manual of Systemic Bacteriology, Vol. 2, Sneath, P.H.A. et al., eds., Williams and Wilkins, Baltimore, Md., 1986). Purified B. coagulans strains have served as a source of enzymes including endonucleases (e.g., U.S. Pat. No. 5,200,336), amylase (U.S. Pat. No. 4,980,180), lactase (U.S. Pat. No. 4,323,651) and cyclo-malto-dextrin glucano-transferase (U.S. Pat. No. 5,102,800). B. coagulans has been used to produce lactic acid (U.S. Pat. No. 5,079,164). A strain of B. coagulans (referred to as L. sporogenes Sakaguti and Nakayama (ATCC 31284)) has been combined with other lactic acid producing bacteria and B. natto to produce a fermented food product from steamed soybeans (U.S. Pat. No. 4,110,477).
Use of a sanitary product produces frequent dermal mucoidal irritations and/or infections associated with the use of the product. Diaper rash is a common issue in both adults and infants. Rashes can become more serious irritations when opportunistic pathogens introduced into the sanitary product germinate and cause infections on these irritated sites. In addition, vulva-vaginal infections are common with the use of napkins and tampons and are typically caused by Candida or Gardnerella species, e.g. Candida albicans and C. tropicalis. Toxic Shock Syndrome and other dermal infections caused by Staphylococcal bacteria, e.g. Staphylococcus aureus and S. epidermidis are also common. Other pathogens which can cause infection after brief periods of dermal irritation and/or use of sanitary products include Trichophyton species, e.g. T. mentagrophytes
In addition, disposable diapers and other sanitary products present environmental problems in their disposal. Sanitary landfills are overused and accumulate excessive amounts of disposed products. Sanitary products such as diapers, sanitary napkins and tampons biodegrade slowly and occupy considerable space due to the bulk of these products, particularly when containing body excrements or fluids which expand due to their absorbent polymer content.
It has now been discovered that probiotic acid-producing bacteria are effective in inhibiting, preventing and/or eliminating dermal/epithelial infections by preventing the growth of dermal pathogens which grow upon use of diapers and other sanitary products.
It has also been discovered that bacterial enzymes and other metabolic products of probiotic acid-producing bacteria play an important role in the biodegradation of many sanitary products, including biodegradation of the waste biomaterials, such as when disposed in landfills.
The invention describes compositions and articles of manufacture containing non-pathogenic probiotic acid-producing bacteria, and their methods of use for inhibiting pathogen growth on skin in applications where sanitary products are used, which also provides for degradation of the sanitary products and body waste products contained thereby. The invention contemplates sanitary products as articles of manufacture which contain effective amounts of a probiotic bacterium in various parts of the product so as to achieve the desired result of inhibiting microbial infections on the tissues in contact with the sanitary product and/or enhance biodegradation of the sanitary product and waste products collected upon the sanitary product.
Typically, the probiotic acid-producing bacteria is introduced into or onto portions of the sanitary product by applying a composition containing viable bacteria to the product during a stage of the manufacture of the sanitary product.
In preferred embodiments, the invention contemplates using a lactic acid-producing bacteria, and more preferably using spore-forming Bacillus species, particularly B. coagulans, being a preferred embodiment, and B. coagulans Hammer being a particularly preferred embodiment.
In one embodiment of the composition, a Bacillus coagulans strain is included in the composition in the form of spores. In another embodiment, a Bacillus coagulans strain is included in the composition in the form of a dried cell mass. In another embodiment, a Bacillus coagulans strain is included in the composition in the form of a stabilized paste. In another embodiment, a Bacillus coagulans strain is included in the composition in the form of stabilized gel.
In one embodiment, the composition further includes an effective amount of a bifidogenic oligosaccharide, such as a short or long chain fructooligosaccharide (FOS), a gluco-oligosaccharide or other long-chain oligosaccharide polymer not readily digested by pathogenic bacteria as described herein.
It should be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention as claimed.
The present invention is directed to the discovery that non-pathogenic acid-producing bacteria (i.e., xe2x80x9cacid bacteriaxe2x80x9d), such as the exemplary Bacillus coagulant, can be used in compositions as a probiotic for inhibiting growth of microbial dermal and epithelial pathogens which can occur upon use of various sanitary products. Typically, these bacteria can be used as a preventative or ameliorative treatment of rashes and other dermal infections that manifest themselves as a result of use of the sanitary product, including irritated/inflamed skin, dermatitis, excema, or skin allergies.
In addition, the invention describes the use of one or more bacteria species to enhance degradation of the sanitary product, which are included in the compositions, methods and articles of manufacture of this invention and are referred to herein as xe2x80x9cdegradative bacteriaxe2x80x9d.
A sanitary product can be any of variety of materials used in contact with a body tissue which, upon use, is susceptible to dermal or epithelial rashes and/or infections. Exemplary sanitary products include an infant or adult diaper, sanitary napkin, tampon, incontinence guard, bed sheet or protector, wound or sore dressing, dermal patch, adhesive tape, saliva absorbent, and related disposable sanitary and hygiene products, although the invention need not be viewed as so limited.
The invention therefore describes various compositions, methods for using the compositions and systems containing the compositions.
In preferred embodiments, the composition further comprises an effective amount of a bifidogenic oligosaccharide, such as fructo-oligosaccharide (FOS), gluco-oligosaccharide (GOS) and the like, as described herein.
A probiotic acid-producing bacteria suitable for use in the methods and compositions of the invention as defined for use in the present invention produces acid and is non-pathogenic. There are many suitable bacteria identified as described herein, although the invention is not limited to currently known bacterial species insofar as the purposes and objectives of the bacteria is described. The property of acid production is key to the effectiveness of the probiotic acid-producing bacteria of this invention because the acid production increases acidity in the local microfloral environment, which does not support growth of many deleterious and undesirable bacteria and fungi. By the mechanism of acid production, the probiotic inhibits growth of competing and deleterious bacteria.
As used herein, xe2x80x9cprobioticxe2x80x9d refers to microorganisms that form at least a part of the transient or endogenous flora and thereby exhibit a beneficial prophylactic and/or therapeutic effect on the host organism. Probiotics are generally known to be safe by those skilled in the art (i.e., non-pathogenic). Although not wishing to be bound by any particular mechanism, the prophylactic and/or therapeutic effect of an acid-producing bacteria of this invention results in part from competitive inhibition of growth of pathogens due to superior colonization, parasitism of undesirable microorganisms, acid production and/or other extracellular products having antimicrobial activity, or combinations thereof. These products and activities of an acid-producing bacteria of this invention act synergistically to produce the beneficial probiotic effect.
Typical acid-producing bacteria (i.e., an xe2x80x9cacid bacteriaxe2x80x9d) useful as a probiotic of this invention are efficient acid producers which include non-pathogenic members of the Bacillus genus, all members of the Lactobacillus and Sporolactobacillus genus, all members of the Bifidobacterium genus, and Pseudomonas limbergii, although certain species are particularly preferred as described herein.
Preferred acid-producing bacteria include the Bacillus laterosporus or Bacillus subtilis species described herein, including Bacillus laterosporus, Bacillus laterosporus BOD, Bacillus laterosporus laubach and Bacillus subtilis.
More preferably, the invention contemplates the use of a lactic acid-producing bacteria (xe2x80x9clactic acid bacteriaxe2x80x9d) which includes the above Lactobacillus, Bifidobacterium and certain Bacillus species. Particularly preferred are lactic acid-producing bacteria, such as L. sporogenes (aka B. coagulans), Sporolactobacillus P44, and Bacillus brevis subsp. coagulans.
Exemplary lactic acid-producing non-pathogenic Bacillus species are Bacillus coagulans, Bacillus coagulans Hammer, Bacillus brevis subspecies coagulans and Bacillus laevolacticus.
Exemplary lactic acid-producing Lactobacillus species include Lactobacillus acidophilus, Lactobacillus bulgaricus, Lactobacillus casei, Lactobacillus cereale, Lactobacillus DDS-1, Lactobacillus delbrukeii, Lactobacillus fermentum, Lactobacillus gaserii, Lactobacillus GG, Lactobacillus jensenii, Lactobacillus rhamnosus, Lactobacillus plantarum, Lactobacillus salivarius, Lactobacillus sporogenes (aka B. coagulans) and Lactobacillus thermophilus.
Exemplary lactic acid-producing Sporolactobacillus species include all Sporolactobacillus species, including Sporolactobacillus P44.
Exemplary lactic acid-producing Bifidobacterium species include Bifidobacterium adolescentis, Bifidobacterium animalis, Bifidobacterium bifidum, Bifidobacterium bifidus, Bifidobacterium breve, Bifidobacterium infantis, Bifidobacterium infaiitus and Bifidobacterium longum.
There are several Bacillus species particularly useful as a probiotic according to the present invention, including the lactic acid-producers Bacillus coagulans, Bacillus laevolacticus.
Although exemplary of the invention, Bacillus coagulans is only a model for the other acid producing species of probiotic bacteria useful in the invention, and therefore the invention is not to be considered as limiting and it is intended that any of the acid producing species of probiotic bacteria can be used in the compositions, therapeutic systems and methods of the present invention.
There are a variety of different Bacillus species useful in the present invention, including, but not limited to many different strains available through commercial and public sources, such as the American Type Culture Collection (ATCC). For example, Bacillus coagulans strains are available as ATCC Accession Numbers 15949, 8038, 35670, 11369, 23498, 51232, 11014, 31284, 12245, 10545 and 7050. Bacillus laevolacticus strains are available as ATCC Accession Numbers 23495, 23493, 23494, 23549 and 23492.
A Bacillus species is particularly suited for the present invention, particularly species having the ability to form spores which are relatively resistant to heat and other conditions, making them ideal for storage (shelf-life) in product formulations, and ideal for survival and colonization of tissues under conditions of pH, salinity, and the like on tissues of the skin and epithelium. Additional useful properties include being non-pathogenic, aerobic, facultative and heterotrophic, rendering these species safe, and able to colonize skin and epithelium.
Because Bacillus spores are heat-resistant and additionally can be stored as a dry power, they are particularly useful for formulation into and manufacture of dry products such as the various sanitary products and compositions described herein. Heat and pressure-resistant spores are also suitable for use in pressure-treated absorbent compositions described herein.
Exemplary methods and compositions are described herein using Bacillus coagulans as a probiotic.
Purified Bacillus coagulans is particularly useful as a probiotic in the present invention. Probiotic B. coagulans is non-pathogenic and is generally regarded as safe (i.e., GRAS classification) by the U.S. Federal Drug Administration (FDA) and the U.S. Department of Agriculture (USDA), and by those skilled in the art. The Gram positive rods of B. coagulans have a cell diameter of greater than 1.0 micrometer (xcexcm) with variable swelling of the sporangium, without parasporal crystal production.
Because B. coagulans forms heat-resistant spores, it is particularly useful for making pharmaceutical compositions that require heat and pressure in their manufacture. Formulations that include viable B. coagulans spores in a pharmaceutically acceptable carrier are particularly preferred for making and using compositions according to the present invention.
The growth of these various Bacillus species to form cell cultures, cell pastes and spore preparations is generally well known in the art. Exemplary culture and preparative methods are described herein for Bacillus coagulans and can readily be used and/or modified for growth of the other lactic acid producing bacteria of this invention.
1. Sources of B. coagulans
Purified B. coagulans bacteria are available from the American Type Culture Collection (Rockville, Md.) using the following accession numbers: B. coagulans Hammer NRS 727 (ATCC# 11014), B. coagulans Hammer strain C (ATCC# 1369), B. coagulans Hammer (ATCC# 31284), and B. coagulans Hammer NCA 4259 (ATCC# 15949). Purified B. coagulans bacteria are also available from the Deutsche Sammlung von Mikroorganismen und Zellkuturen GmbH (Braunschweig, Germany) using the following accession numbers: B. coagulans Hammer 1915 (DSM# 2356), B. coagulans Hammer 1915 (DSM# 2383, corresponds to ATCC# 11014), B. coagulans Hammer (DSM# 2384, corresponds to ATCC# 11369), and B. coagulans Hammer (DSM# 2385, corresponds to ATCC# 15949). B. coagulans bacteria can also be obtained from commercial suppliers such as Sabinsa Corporation (Piscataway, N.J.) or K.K. Fermentation, Kyoto, Japan.
These B. coagulans strains and their growth requirements have been described previously (Baker et al, Can. J. Microbiol. 6:557-563, 1960; Blumenstock, xe2x80x9cBacillus coagulans Hammer 1915 und andere thermophile oder mesophile, sxc3xa4uretolerante Bacillus-Arten-eine taxonomische Untersuchungxe2x80x9d, Doctoral thesis, Univ. Gxc3x6ttingen, 1984; Nakamura et al, Int. J. Syst. Bacteriol., 38:63-73, 1988). Strains of B. coagulans can also be isolated from natural sources (e.g., heat-treated soil samples) using well known procedures (Bergey""s Manual of Systemic Bacteriology, Vol. 2, p. 1117, Sneath, P.H.A. et al., eds., Williams and Wilkins, Baltimore, Md., 1986). The results described herein were obtained with B. coagulans Hammer obtained from the American Type Culture Collection (ATCC# 31284) which was grown as described herein and stored in lyophilized aliquots at xe2x88x9280xc2x0 C. All B. coagulans that exhibit the properties described herein are considered equivalents of this strain.
B. coagulans had previously been mischaracterized as a Lactobacillus in view of the fact that as originally described, this bacterium was labeled as Lactobacillus sporogenes (See Nakamura et al, Int. J. Syst. Bacteriol., 38:63-73, 1988). However, this was incorrect because B. coagulans produces spores and through metabolism excretes L(+)-lactic acid, both aspects which provide key features to its utility. Instead, these developmental and metabolic aspects required that the bacterium be classified as a lactic acid bacillus, and therefore it was renamed.
It is also not generally appreciated that classic Lactobacillus and/of Bifidobacterium species are unsuitable for industrial manufacturing processes due to their instability in high temperature environments, their baro-intolerance, and their other growth requirements. These factors make these bacteria less desirable for use in products and compositions which require industrial/manufacturing processes. In contrast, the preferred Bacillus species can survive very harsh manufacturing environments and remain viable in spore-state for extended periods of time, when kept dry and maintained below 120 Degrees F.
2. Growth of B. coagulans
B. coagulans is aerobic and facultative, grown typically in nutrient broth, pH 5.7 to 6.8, containing up to 2% (by wt) NaCl, although neither NaCl nor KCl are required for growth. A pH of about 4 to about 7.5 is optimum for initiation of growth from spores. It is optimally grown at about 30xc2x0 C. to about 45xc2x0 C., and the spores can withstand pasteurization. It exhibits facultative and heterotrophic growth by utilizing a nitrate or sulphate source. Additional metabolic characteristics of B. coagulans are summarized in Table 1.
B. coagulans can be grown in a variety of media, although it has been found that certain growth conditions produce a culture which yields a high level of sporulation. For example, sporulation is enhanced if the culture medium includes 10 milligrams per liter of manganese sulfate, yielding a ratio of spores to vegetative cells of about 80:20. In addition, certain growth conditions produce a bacterial spore which contains a spectrum of metabolic enzymes particularly suited for the present invention, i.e., production of lactic acid and enzymes for the enhanced probiotic activity and biodegradation. Although spores produced by these particular growth conditions are preferred, spores produced by any compatible growth conditions are suitable for producing a B. coagulans useful in the present invention.
Suitable media for growth of B. coagulans include Nutristart 701, PDB (potato dextrose broth), TSB (tryptic soy broth) and NB (nutrient broth), all well known and available from a variety of sources. Media supplements containing enzymatic digests of poultry and fish tissue, and containing food yeast are particularly preferred. A preferred supplement produces a media containing at least 60% protein, and about 20% complex carbohydrates and 6% lipids. Media can be obtained from a variety of commercial sources, notably DIFCO (Detroit, Mich.), Oxoid (Newark, N.J.), BBL (Cockeyesville, Md.), Advanced Microbial Systems, (Shakopee, Minn.), and Troy Biologicals (Troy, Mich.).
A preferred procedure for preparation of B. coagulans is described in the Examples.
3. Probiotic Antimicrobial Activity of B. coagulans
One aspect of the utility of B. coagulans in the present invention is based on the ability of probiotic B. coagulans to inhibit growth of pathogenic enteric microorganisms as described in the Examples. Pathogenic bacteria inhibited by B. coagulans activity include Staphylococcus aureus, S. epidermidis, Streptococcus pyogenes, S. spp., Pseudomonas aeruginosa, Escherichia coli (enterohemorragic species), Clostridium species including C. perfingens, C. difficile, C. difficile, C. botulinum, C. tributrycum, and C. sporogenes, Gardnerella vaginalis, Propionibacterium acnes, Aeromonas hydrophilia, Candida species, Proteus species, Klebsiella species, fungal dermatophytes or other mycotic pathogens. These pathogens can cause a variety of pathologies including disruption of normal tissue function, and the like conditions as are well known in the art. Therefore, use of compositions containing a probiotic that inhibits these pathogens are useful in preventing or treating conditions associated with infection by these pathogens.
Although B. coagulans is exemplary, by virtue of the common properties of an acid-producing bacteria, a therapeutic composition comprising an acid bacterium of this invention can be used in a method or composition of this invention.
4. Extracellular Products Having Antimicrobial Activity
B. coagulans cultures contain secreted products which have antimicrobial activity. These secreted products are useful in therapeutic compositions according to the present invention. Cell cultures are harvested as described herein, and the culture supernatants are collected, by filtration or centrifugation, or both, and the resulting supernatant contains antimicrobial activity useful in a therapeutic composition. The preparation of a B. coagulans extracellular product is described in the Examples.
Extracellular products of B. coagulans may be included in compositions for use in the invention. In particular, an effective amount of an extracellular product can be applied to a structural component part of a sanitary product of this invention, such as a diaper, bandage, sanitary napkin, tampon and the like product.
In one embodiment, the invention contemplates that the bacteria used in a sanitary product, system or related method according to the present invention have the ability to support biodegradation of the product as an additional feature of the invention. To that end the product, system or method comprises a degradative bacteria as described herein.
A degradative bacteria, or xe2x80x9cdegradation-enhancingxe2x80x9d non-pathogenic bacteria, can be any of the bacteria previously recited which are defined as a probiotic acid-producing bacteria herein which have the property of being a degradative bacteria, or can be a different bacteria, such that two different species of bacteria are used in practicing the invention. That is, is one embodiment both a probiotic acid-producing bacteria and a degradative bacteria are included in a composition, product, system or method according to the present invention.
Typical bacterial are any non-pathogenic bacteria which promotes degradation of human waste products, and preferably also can degrade the absorbent materials of the sanitary product of the present invention. A preferred bacteria is any non-pathogenic member of the Bacillus genus, Lactobacillus genus, Sporolactobacillus genus, Bifidobacterium genus, Pseudomonas genus, and the like bacteria.
Particularly preferred members of the Bacillus genus include Bacillus acidocaldarius, Bacillus alcalophilus, Bacillus azotoformans, Bacillus badius, Bacillus brevis, Bacillus brevis subsp. coagulans, Bacillus cereus, Bacillus chitinosporus, Bacillus circulans, Bacillus coagulans, Bacillus dextrolacticus, Bacillus firmus, Bacillus globisporus, Bacillus hydrophilus, Bacillus laevolacticus, Bacillus laterosporus, Bacillus laterosporus BOD, Bacillus laterosporus Laubach, Bacillus lentus, Bacillus licheniformis, Bacillus macerans, Bacillus marinus, Bacillus megaterium, Bacillus modestus, Bacillus mycoides, Bacillus pantothenticus, Bacillus pumilus, Bacillus polymyxa, Bacillus smithii, Bacillus stereothermophilus, Bacillus subtilis, Bacillus thermoacidurans, Bacillus thuringiensis, Bacillus uniflagellatus, and the like.
Particularly preferred members of the Pseudomonas genus include Pseudomonas alcaligenes, Pseudomonas limbergii, Pseudomonas pseudoalcaligenes, Pseudomonas 679-2.
Particularly preferred members of the Bifidobacterium genus include Bifidobacterium adolescentis, Bifidobacterium animalis, Bifidobacterium bifidum, Bifidobacterium bifidus, Bifidobacterium breve, Bifidobacterium infantis, Bifidobacterium infantus, Bifidobacterium longum, and the like.
Particularly preferred members of the Lactobacillus genus include Lactobacillus acidophilus, Lactobacillus bulgaricus, Lactobacillus casei, Lactobacillus cereale, Lactobacillus delbrukeii, Lactobacillus DDS-1, Lactobacillus fermentum, Lactobacillus gaserii, Lactobacillus GG, Lactobacillus jensenii, Lactobacillus plantarum, Lactobacillus rhamnosus, Lactobacillus salivarius, Lactobacillus sporogenes, Lactobacillus thermophilus, and the like.
A preferred member of the Sporolactobacillus genus include Sporolactobacillus P44.
Degradation of waste products or sanitary products can be readily assessed by any of a variety of processes, and therefore the term xe2x80x9cdegradation-enhancingxe2x80x9d is not to be construed as so limited to any particular degree or rate of enhancement of degradation.
The above bacteria are well known in the bacterial arts, and can be obtained from well known sources and propogated by well known methods. An exemplary source is the American Type Culture Collection, although other culture banks are also available. The culturing of bacteria is also well known, and praticularly the preparation of spores for the sporulating varieties of bacteria, which are particularly preferred.
Bifidogenic oligosaccharides, as used in the context of the present invention, are a class of sugars particularly useful for preferentially promoting the growth of a lactic acid bacteria of this invention. These oligosaccharides include fructo-oligosaccharides (FOS), gluco-oligosaccharides (GOS), other long-chain oligosaccharide polymers of fructose and/or glucose, and the trisaccharide raffinose, all of which are not readily digested by pathogenic bacteria. The preferential growth is promoted due to the nutrient requirements of this class of lactic acid bacterium as compared to pathogenic bacteria. Bifidogenic oligosaccharides are polymers that are utilized almost exclusively by the indigenous Bifidobacteria and Lactobacillus and can be similarly utilized by Bacillus. Deleterious microorganisms such as Clostridium, Candida, Campylobacter, Klebsiella, Pseudomonas, Staphylococcus, Salmonella and E. coli cannot metabolize FOS or other bifidogenic oligosaccharides, and therefor use of these bifidogenic oligosaccharides in combination with a lactic acid bacteria of this invention, particularly Bacillus, allows the beneficial and probiotic bacteria to grow and to replace any undesirable or pathogenic microorganisms.
The use of bifidogenic oligosaccharides in compositions of the present invention provides a synergistic effect thereby increasing the effectiveness of the probiotic-containing compositions of this invention. This synergy is manifest at least by selectively increasing the ability of the probiotic bacterium to grow by increasing the food supplement for probiotic bacteria which preferentially selects for growth of the probiotic bacteria over many other bacterial species in the infected tissue. In addition, it is understood that Bifidobacteria and Lactobacillus are also producers of lactic acid. Bifidogenic oligosaccharides enable these probiotic organisms to proliferate preferentially over the undesirable bacteria that may be present in the tissue to be treated by the present invention, thereby furthering the probiotic state of the body. Thus, the presence of the bifidogenic oligosaccharides in the formulation allows for more effective inhibition of undesirable microbes by increasing the ability of all varieties of beneficial probiotic bacteria to grow and therefore provide benefit.
The bifidogenic oligosaccharide can be used either alone or in combination with a lactic acid bacterium in a composition. That is, due to the growth promoting activity of bifidogenic oligosaccharides, the invention also contemplates a composition comprising a bifidogenic oligosaccharide of this invention in a lactic acid bacterium growth-promoting amount. As shown herein, these amounts can vary widely since a probiotic lactic acid bacterium will respond to any metabolic amount of nutrient oligosaccharide, and therefore the invention need not be so limited.
A preferred and exemplary bifidogenic oligosaccharide is FOS, although the other sugars can also be utilized, either alone or in combination.
FOS can be obtained from a variety of natural sources, including commercial suppliers. As a product isolated from natural sources, the components can vary widely and still provide the beneficial agent, namely FOS. FOS typically has a polymer chain length of from about 4 to 100 sugar units, with the longer lengths being preferred. For example, the degree of purity can vary widely so long as functional FOS is present in the formulation. Preferred FOS formulations contain at least 50% by weight of fructooligosaccharides compared to simple (mono or disaccharide) sugars such as glucose, fructose or sucrose, preferably at least 80% fructooligosaccharides, more preferably at least 90% and most preferably at least 95% fructooligosaccharides. Sugar content and composition can be determined by any of a variety of complex carbohydrate analytical detection methods as is well known.
Preferred sources of FOS include inulin, Frutafit IQ (tm) from Imperial Suiker Unie (Sugar Land, Tex.), NutraFlora (tm) from Americal Ingredients, Inc., (Anaheim, Calif.), Fabrchem, Inc., (Fairfield, Conn), and Fruittrimfat Replacers and Sweeteners (Emeryville, Calif.). Bifidogenic oligosaccharides such as GOS, and other long chain oligosaccharides are also available from commercial vendors.
The present invention is directed to the discovery that lactic acid bacteria, particularly Bacillus species, can be used in compositions as a probiotic in combination with sanitary products for inhibiting dermal and epithelial microbial infections associated with the use of sanitary products. As discussed further, the compositions can be formulated in many configurations because the bacterium can be presented as a viable organism, e.g., as a vegetative cell or as a spore depending on the species and form of probiotic organism, and colonize tissues associated with use of a sanitary product. The cells/spores can be presented in a variety of compositions suited for use in a sanitary product.
The active ingredients, i.e., live bacteria or extracellular components, comprise about 0.1% to about 50% by weight of the final composition, preferably 1% to 10% by weight in the composition.
A typical composition will contain in a one gram dosage formulation a concentration of from 103 to 1014 colony forming units (CFU) of viable acid bacterium (i.e., vegetative cell) or bacterial spore, preferably 105-1012 colony forming units/g, whereas in other preferred embodiments the concentrations are 109-1013 colony forming units/g, 105-107 colony forming units/g, or 108-109 colony forming units/g.
In one embodiment, a composition for use in a sanitary product according to the present invention can further comprise a degradation-enhancing bacteria as described herein. A preferred amount of this bacteria is an amount sufficient to promote degradation, which can be from about 104 to 1014 CFU of viable bacteria for use per unit of sanitary product, preferably about 107 to 1010 CFU per unit, and more preferably about 108 to 1019 CFU per unit. The actual amount in a composition will vary depending upon the amounts of composition to be dispersed into the absorbent structure or other portions of the sanitary product, and upon routes of dispersal.
In addition, it is contemplated that combinations of bacteria may be utilized to afford optimized formulations depending upon the circumstances. Thus, various combinations of species of bacteria may be used, and in varying amounts, so long as the primary objective is to provide a probiotic acid bacteria, and the secondary objective is to provide a degradation-enhancing bacteria.
In a preferred embodiment, the invention contemplates certain preferred combinations. In particular, a mixture of bacterial spores is ideally suited for manufacturing and shelf storage. A preferred embodiment utilizes a dispersion of about one billion CFU of B. coagulans spores mixed with about one billion CFU of degradation enhancing bacterial spores, preferably an equal mix of B. licheniformis, B. subtilis, B. pumilis and B. megaterium.
In one preferred embodiment a composition may further include from about 10 milligrams (mg) to one gram of a bifidogenic oligosaccharide, preferably a fructooligosaccharide. The composition typically contains a lactic acid bacterium growth-promoting amount of the bifidogenic oligosaccharide, which growth-promoting amount can vary widely and be readily measured by growth assays as described herein. The composition will typically contain 10 mg to 1 gm of bifidogenic oligosaccharide per gram of composition depending on the dosage, route of administration and intended usage.
The formulation for a composition of this invention may include other probiotic agents or nutrients for promoting spore germination and/or bacterial growth. A particularly preferred material is a bifidogenic factor which promotes growth of beneficial probiotic bacteria as described herein.
The compositions may also include known antimicrobial agents, known antiviral agents, known antifungal agents, all of which must be compatible with maintaining viability of the Bacillus active agent when Bacillus organisms or spores are the active agent. The other agents in the compositions can be either synergists or active agents. Preferably, the known antimicrobial, antiviral and/or antifungal agents are probiotic agents compatible with Bacillus. The compositions may also include known antioxidants, buffering agents, and other agents such as coloring agents, flavorings, vitamins or minerals. Thickening agents may be added to the compositions such as polyvinylpyrrolidone, polyethylene glycol or carboxymethylcellulose.
Chemicals used in the present compositions can be obtained from a variety of commercial sources, including Spectrum Quality Products, Inc (Gardena, Calif.), Seltzer Chemicals, Inc., (Carlsbad, Calif.) and Jarchem Industries, Inc., (Newark, N.J.).
The active agents are combined with a carrier that is physiologically compatible with the dermal or epithelial tissue of a human or animal to which it is administered. That is, the carrier is preferably substantially inactive except for surfactant properties used in making a suspension of the active ingredients. The compositions may include other physiologically active constituents that do not interfere with the efficacy of the active agents in the composition.
A formulated composition of this invention may be completed in weight using any of a variety of carriers and/or binders. A preferred carrier is micro-crystalline cellose (MCC) added in an amount sufficient to complete the one gram dosage total weight. Particularly preferred formulations for a composition of this invention are described in the Examples.
Carriers can be solid-based dry materials for formulations in tablet, granule or powdered form, and can be liquid or gel-based materials for formulations in liquid or gel forms, which forms depend, in part, upon the manner of use or the manner of manufacturing a sanitary product.
Typical carriers for dry formulations include trehalose, malto-dextrin, rice flour, micro-crystalline cellulose (MCC) magnesium stearate, inositol, FOS, gluco-oligosaccharides (GOS), dextrose, sucrose, and the like carriers.
Where the composition is dry and includes evaporated oils that produce a tendency for the composition to cake (adherence of the component spores, salts, powders and oils), it is preferred to include dry fillers which distribute the components and prevent caking. Exemplary anti-caking agents include MCC, talc, diatomaceous earth, amorphous silica and the like, typically added in an amount of from about 1 to 95% by weight.
The carrier is preferably a formulation in which, for example, B. coagulans can be suspended for hydration by the user before it is administered to the sanitary product or tissue.
Suitable liquid or gel-based carriers are well known in the art, such as water and physiological salt solutions, urea, alcohols and glycols such as methanol, ethanol, propanol, butanol, ethylene glycol and propylene glycol, and the like. Preferably, water-based carriers are about neutral pH.
In a related embodiment, the invention describes an aqueous liquid absorbent composition comprising an aqueous liquid absorbing medium (i.e., an xe2x80x9cabsorbentxe2x80x9d) and a microbe-inhibiting amount of an extracellular product isolated from B. coagulans as described herein. The absorbent composition is similar to an absorbent structure described herein for a sanitary product insofar as the composition in the absorbent portion of the sanitary product. The composition is formulated to be added to or dispersed into/onto a sanitary product for use of the product according to the methods described for a sanitary product of the present invention, that is to inhibit microbial growth upon use of the product.
The composition containing absorbent and the extracellular product is typically produced by admixing the extracellular product with a preselected amount of absorbent, and drying or desiccating the admixture to coat the absorbent medium with the microbe-inhibiting extracellular product. The resulting dry composition can be applied directly onto a conventional sanitary product.
The manufacture of a composition comprising the absorbent and the extracellular product involves admixing a microbe-inhibiting amount extracellular product prepared as described herein, typically in the ratio of 0.1 to 1 ml of supernatant pet gram of absorbent, and thereafter drying the absorbent medium to form the microbe-inhibiting absorbent composition.
The absorbent composition may further contain a degradation-enhancing bacteria as described herein in amounts similar to the amounts used in a sanitary product on a weight and volume basis. The absorbent composition may also contain a bifidogenic oligosaccharide as described herein.
A preferred composition according to the present invention is an aqueous liquid absorbent composition that comprises an aqueous liquid absorbing medium and an effective amount of a viable acid bacteria according to the present invention, also referred to as an anti-microbial absorbent composition. This composition is useful for application directly onto a sanitary product and has both the absorbent and microbe inhibiting properties described herein.
The acid bacteria can be any of the various bacteria described herein, with lactic acid bacteria preferred, and B. coagulans being particularly preferred. The bacteria is typically provided in the composition in the form of dried cells, a dried cell mass or as spores in powder, and can also be formulated into a liquid, paste, powder, granule or pellet formulation.
An absorbent anti-microbial composition typically contains about 102 to 1014 CFU viable probiotic acid bacteria per cubic meter of composition, preferably contain about 103 to 1010 CFU, more preferably contain 103 to 106 CFU or 106 to 109 CFU, and in preferred embodiments contain 108 to 109 CFU per cubic meter of absorbent composition.
The aqueous liquid absorbing medium can be any of the materials described for an absorbent structure herein, and need not be limited.
The absorbent composition can further comprise a bifidogenic oligosaccharide as described herein for an absorbent product, and typically is present in amounts of about 10 mg to 1 gm of oligosaccharide per cc of composition, and preferably about 100 to 500 mg oligosaccharide per cc of composition.
The invention is directed at methods for increasing dermal and mucoidal health and inhibiting microbial infections and microbial growth associated with use of sanitary products. The method comprises the use of a sanitary product comprising a viable non-pathogenic lactic acid bacteria, which bacterial promote dermal probiosis. In a related embodiment, one can administer a composition of the present invention to a pre-existing sanitary product, and use the product. In either case, the use of the sanitary product containing bacteria provides contact between the tissue in which the probiotic effect is targeted and the sanitary product, and thereby contacts the target tissue with an effective amount of the active probiotic ingredients in the composition.
The invention describes methods for inhibiting dermal or epithelial infections comprising the steps of contacting the surface of a sanitary product of this invention with the skin or mucous membrane of a mammal and maintaining the contact for a time period sufficient to allow initiation of probiotic activity of the lactic acid bacteria or spores in the sanitary product, thereby inhibiting microbial growth adjacent to or on the skin or mucous membrane contacted by the sanitary product.
Typically, the surface of the sanitary product used in the present method is present on a flexible article selected from the group consisting of a diaper, pliable material for wiping skin or a mucous membrane, dermal patch, adhesive tape, absorbent pad, clothing, tampon, panty protector, incontinence guard, sanitary napkin or the like product.
The method can be practiced to inhibit any of a variety of infections and/or irritations known to arise upon use of a sanitary product, including but not limited to diaper rash, eczema, incontinence, menstruation, fluid discharges from wounds and other dermal/epithelial infections or inflammations caused by opportunistic microbial pathogens that overgrow as a result of the irritated or inflamed skin/epithelial tissue, dermatitis, eczema, skin allergies, and the like due to use of the sanitary product.
Typically, the mammal is a human, although the methods and compositions of the invention can be applied to any mammal which would require the use of a sanitary product where dermal infections/inflammations could be problematic.
Typically, the non-pathogenic lactic acid bacteria is used according to the present invention by applying a sanitary product to a tissue, which product already contains an effective amount of the bacteria incorporated into portions of the sanitary product. Alternatively, a composition of the bacterial may be applied to the sanitary product prior to use. Administration of a composition of this invention to a sanitary product is preferably made using a gel, suspension, spray, powder or semi-solid formulation containing viable bacteria, bacterial spores and/or probiotic extracellular product, all formulated using GMP xe2x80x9c(good manufacturing practicexe2x80x9d) methods well known in the art. Administration comprises use of typically 0.001 (i.e, 10,000 CFU) to 10 billion colony forming units (CFU) of viable bacteria or spore applied to a unit of sanitary product, although lesser or greater amounts may also be used. Application is preferably by way of spray-drying a spore/bacteria/extracellular product liquid suspension onto the sanitary product""s absorbent structure, preferably onto the region of the sanitary product which directly contacts the dermal/epithelial tissue upon use.
Upon use of the sanitary product, the absorbent structure acquires a body fluid, such as urine, excess fluid of fecal matter, blood, tissue exudate, pus, and the like depending upon the type of sanitary product, whereupon the fluid comes into contact with the lactic acid bacteria present in the sanitary product. The bacteria germinates or is motivated to grow as a result of the contact with the body fluid, and using the electrolytes and substrates present in the body fluid proliferates. Upon growth, the bacterial produces metabolites that are effective in mitigating mycotic growth and other microbial pathogens. In addition, the growth of the bacterial feeds on the body fluid waste, and produces enzymes with facilitate degradation of the sanitary product. After the sanitary product is removed and disposed into a landfill, the bacterial continue to grow and degrade the waste and materials present in the construction of the sanitary product.
In preferred embodiments where a bifidogenic oligosaccharide is included in a composition of this invention, such as FOS, there is a synergy provided in the form of a selective food supply, as described herein, resulting in selective growth of acid bacteria over food supply-driven growth of pathogenic bacterial.
The method comprises administration of a composition of this invention containing the active ingredients to a human or animal in various dosage regimens as described herein to achieve the nutritional result.
The method is typically practiced on any animal where inhibiting microbial infection is desired. Typically, a human in the preferred user of a sanitary product or composition according to the present invention, although the invention can be practiced on any mammal. The mammal can be any livestock or zoological specimen where such inhibition of parasites/pathogens provides economic and health benefits. Any animal can benefit by the claimed methods, including horses, cows, sheep, goats, pigs, and the like domesticated animals. Other purposes are readily apparent to one skilled in the arts of sanitary products.
In carrying out the methods of the invention, it is appreciated that there are multiple benefits and advantages. In particular, it is noted that the presence of the lactic acid bacteria will promote degradation of used sanitary products, when used either alone or in combination with other bacteria. In addition, as shown herein, a viable lactic acid bacterial growth will exhibit a beneficial probiotic effect onto the skin or epithelial tissue adjacent to the sanitary product in use by out-competing dermal/epithelial pathogens, and by production of extracellular metabolites that inhibit dermal/epithelial pathogens.
In a related embodiment, the invention contemplates a method for enhancing biodegradation of a sanitary product comprising the step of providing an inoculum of viable non-pathogenic lactic acid bacteria according to this invention into the sanitary product, and contacting the sanitary product to the body tissue for use as prescribed/intended for the sanitary product. The presence of the provided inoculum in the used sanitary product together with the collected body fluids/exudates provides an environment for bacterial growth, which facilitates the breakdown of the various components of the sanitary product, including the waste material containing in the disposed sanitary product and the various components making up the sanitary product, such as cellulose, petroleum hydrocarbon polymers, natural and synthetic fibers and adhesives, and the like materials described herein for constructing a sanitary product.
As noted above, enhancement of degradation of a sanitary product upon disposal can be facilitated by use of a lactic acid bacteria. In a particular embodiment, the method comprises the use of a non-pathogenic lactic acid bacteria and comprises the use of one or more additional species of bacteria designed to enhance degradation. These additional bacteria are non-pathogenic insofar as they are included in the sanitary product, but are not necessarily probiotic in terms of inhibiting dermal or epithelial microbial infections. Rather, these additional bacteria are included solely for the ability to enhance degradation, and are referred collectively as xe2x80x9cdegradation-enhancingxe2x80x9d bacteria.
The invention also contemplates various articles of manufacture which utilize the beneficial aspects of the present invention by combination of a composition with various medical or personal hygiene devices so as to reduce or prevent microbial infections associated with the use of these devices. The invention comprises compositions of a probiotic acid bacteria, preferably a lactic acid bacteria, and more preferably a Bacillus species and/or isolated B. coagulans active agent, applied to a solid surface or impregnated into a solid matrix of any device or article of manufacture that is intended to be in contact with skin or a mucous membrane. Preferably the solid surface is a flexible article than can be worn on or wiped on the skin or mucous membrane. More preferably, when the flexible item carrying the acid bacteria is to be worn on the skin it includes a means for attaching the article to the skin such as, for example, an adhesive layer, interengaging hook and pile (Velcro(copyright)) connectors, or other well known means of attachment such as ties, snap closures, elastic, buttons and the like.
Many different types of absorbent products having absorbent structures are well known in the art, and can include diapers, towelettes (e.g., baby wipes or feminine hygiene towelettes), sanitary napkins, tampons, panty protectors, dermal patches, adhesive tape, bandages, wound or sore dressings, absorbent pads, incontinence guards, bed sheets or protectors, saliva absorbent, articles of clothing (e.g., underclothes, sleeping apparel), bath towels, wash cloths, and the like.
Thus the invention describes an absorbent product comprising an aqueous liquid absorbent structure and an effective amount of viable non-pathogenic acid bacteria according to the present invention.
Absorbent structures in sanitary products (absorbent products) are typically produced by fluffing cellulosic or other fibrous pulp into a roll, bale or sheet for instance, to form a pulp mat, sometimes admixed with so-called superabsorbent materials in the pulp mat. The superabsorbent materials are typically polymeric formulations capable of absorbing many times their own weight of water of body fluid, and are well known in the art. The pulp mat is typically compressed so as to enhance its fluid-wicking ability and also in order to reduce pulp body bulk, and therewith obtain an article which is as compact as possible to achieve the absorbent properties desired in the particular sanitary product.
The absorbent structure may also include other constituents, for instance components which will improve fluid acquisition properties, fluid-wicking properties, fluid retention properties, and the like well known in the art. Other included constituents include components which increase coherent strength, i.e., the ability to withstand deformation during use.
The absorbent structure may contain fibrous woven, knitted or non woven materials, occlusive or non occlusive films or membranes, granules, pellets or aggregates of absorbent material, synthetic polymer fibers, films, membranes and foams (e.g., nylon, polytetrafluoroethylene (PTFE, such as Teflon(copyright) or Gor-Tex(copyright)), polystyrene, polycarbonate, polyvinylchloride and polysulphone). All of these forms are well known in the art and include, for example, knitted or woven fabrics, non woven fabrics such as felt and batting, fiber balls of cotton, rayon, cellulose or synthetic fibers and the like materials.
The fibers can be natural fibers, including but not limited to wool, silk, cotton, cellulosic fiber, and the like natural fibers. Natural polymers based on polysaccharide can also be used, including but not limited to modified cellulose and cellulose derivatives, e.g., alkyl-, hydroxyalkyl-, carboxymethylcellulose, gum resins, e.g., guar gum, locust bean gum, tragacanth gum, gum arabic, pectin, etc., starch and starch derivatives, such as corn starch, grain starch, potato starch, amylose, amylopectin, dextrin, dextran, modified starch, hydroxy-ethyl starch, cationic starch, starch graft polymers, and the like polymers. The fibers can be synthetic fibers, including but not limited to polyester, polyolefin, polyamide, polyvinyl alcohol, polyvinyl acetate, polyvinyl chloride, polyvinyl urea, polyurethane, polyurea, polyacrylonitrile, as well as copolymers of these polymers, and the like synthetic fibers.
The absorbent product can be formatted into a multi layer configuration, having an absorbent structure layer, a fluid permeable top layer which allows wicking of fluid but is itself non-wettable due to its structural composition (e.g., synthetic fiber construction), and a fluid-impermeable bottom layer (i.e, back sheet) which prevents absorbed fluid to pass from the absorbent structure layer to the adjacent tissues of the user when contacted by the absorbent product during use. Such layered configurations are well known in the diaper and panty liner arts, and need not be described in detail.
The absorbent product typically contains about 102 to 1014 CFU of viable probiotic acid bacteria per cubic meter (M3) of absorbent product, and is typically dispersed in the form of cells, dried cell mass or spores, with spores being the particularly preferred format. Preferably, the product will contain about 103 to 1010 CFU per M3 of absorbent product, and may have 103 to 106 CFU per M3 or 106 to 109 CFU per M3, and preferably will have 108 to 109 CFU per M3 of absorbent product, although these amounts can vary depending upon the specific application, product formulation and intended use.
The absorbent product may further contain a bifidogenic oligosaccharide dispersed therein as described for a composition according to the present invention, typically in amounts of from about 10 milligrams (mg) to 1 gram per cubic centimeter (cc) of absorbent structure, and preferably about 100 to 500 mg of oligosaccharide per cc of structure.
The absorbent product may further contain a degradation-enhancing bacteria according to the present invention, as described herein. Where the degradation-enhancing bacteria is different from the probiotic acid-producing bacteria, the degradation enhancing bacteria can be incorporated into the absorbent product is regions of the product designed to keep the bacteria away from the skin or tissues of the mammal during use, and designed for release or access to the waste products. Typically, an absorbent product will contain from 104 to 1014 CFU of viable degradation-enhancing bacteria per unit of sanitary product, preferably about from 107 to 1010 CFU per unit, and more preferably about from 108 to 109 CFU per unit.
A composition containing a lactic acid bacteria of this invention can be applied to any of a variety of regions of an absorbent product of the present invention including the moisture barrier (stay-dry lining), the absorbent structure (e.g., moisture absorbing polymer), coated onto the external surface that contacts the skin or epithelial tissue, in capsules which are sealed off until wetted for slow release of bacteria/spores, or combinations thereof. The bacteria can be presented as a spore, a dry or lyophilized cell mass, a stabilized gel or paste, a dry powder, or as a component of the gel polymer that comprises the moisture barrier system.
In addition, insofar as the Bacillus coagulans extracellular product (xe2x80x9cisolated agentxe2x80x9d) can be used to inhibit microbial pathogens, the invention contemplates the use of the extracellular product in place of or in combination with a viable acid bacteria in any of the sanitary products described herein.
The acid bacteria and/or a B. coagulans isolated active agent can be applied to the solid surface using any of a variety of known methods including, for example, applying a powder, spray drying the probiotic onto the material or soaking the material in a solution containing the probiotic and then using the wetted material or drying the material before use. Porous material may contain the Bacillus and/or the isolated active agent in the pores or interstices of the solid material. The Bacillus and/or the isolated active agent can be attached by adhesion, such as by attachment to an adhesive layer that is then applied to the skin (e.g., in a bandage or dermal patch). The Bacillus and/or the isolated active agent can be impregnated into the solid material during the manufacturing process of the flexible article (e.g., added to a synthetic composition before or during the polymerization process). The pressure and heat resistance of Bacillus spores makes them particularly suitable for incorporation into the material during manufacturing.
Any of the solid materials carrying Bacillus and/or the isolated active agent can be packaged individually or in groups, suitable for holding the treated material using standard packaging materials (e.g., in a shrink wrapper, sealed packet, protective wrapper or dispensing container suitable for holding dry or wet materials).
The article of manufacture can have applied thereon any of the additional/optional components of a composition of this invention, including carriers, disinfectants, antibacterial agents, salts, FOS, and the like. In particular, the absorbent product can include as a component part of the absorbent structure inert ingredients, neutral filling agents and the like. Exemplary neutral filling agents include peat, sand, clay, garden mold, ground shells of nuts or pomaceous fruit, wood flour, chitin-containing flour, and the like well known materials.
Any of a variety of methods for placing the composition onto a subject article can be used, and therefor the invention need not be so limited. However, preferred methods include a xe2x80x9cspray-dryxe2x80x9d method in which the material is exposed in a low humidity chamber to an atomized mix containing a liquid composition, where the chamber is subsequently exposed to about 80-110 degrees Fahrenheit to dry the liquid, thereby impregnating the material of the article with the components of the composition. A typical load is from 105 to 109 cfu of bacteria/spores per ml of atomizing mix, to place that same amount on about one square inch of external surface of fibrous carrier/article material. The dry article is then ready for storage in a sterile package for use.
In one embodiment, the invention contemplates the use of viable probiotic acid bacteria in absorbent structures which structures are incorporated into an absorbent product as described herein. Thus, the invention describes the use of an effective amount of probiotic acid bacteria where the bacteria is dispersed or incorporated in the form of dried cells or cell mass or as spores into the absorbent structure of an absorbent product according to the invention.
The invention further contemplates a system for inhibiting dermal or epithelial infection associated with use of a sanitary product comprising a container comprising label and an absorbent composition according to the present invention, wherein said label comprises instructions for application of the absorbent composition for inhibiting microbial infections during use of the sanitary product.
Typically, the system is present in the form of a package containing a composition or absorbent product of this invention, or in combination with packaging material. The packaging material includes a label or instructions for use of the components of the package. The instructions indicate the contemplated use of the package component as described herein for the methods or compositions of the invention.
For example, a system can comprise one or more unit dosages of a composition according to the invention. Alternatively, the system can contain bulk quantities of a composition. The label contains instructions for using the composition or absorbent product as appropriate, and may include information regarding storage of the composition or absorbent product, application methods, health indications, methods for disposal, and the like information.
Unless defined otherwise, all scientific and technical terms used herein have the same meaning as commonly understood by those skilled in the relevant art. Unless mentioned otherwise, the techniques employed or contemplated herein are standard methodologies well known to one of ordinary skill in the art. The examples of embodiments are for illustration only.

Absorbent product containing absorbent structure and Bacillus coagulans


A novel craft art form product, system and method including patterns, paint, and applicators enables craft paint to form three-dimensional color bead matrix patterns having high degree of visual resolution and color saturation. Precisely located and closely spaced geometric shapes associated with a set of color symbols are used to form matrix designs in patterns. Each symbol represents an artistic expression which is assigned to a particular color. Each color symbol has a color darkness value which may also correspond to the darkness value of the assigned color. The craft paint material has the characteristics of forming a discrete substantially uniform and homogeneous, three-dimensional bead to overlay the color symbol associated with each geometric shape. The craft paint material can form discrete beads placed closely together without running together, yet retain sufficient fluidity to settle into smooth, substantially uniform beads. A fine tip applicator applies the craft paint material to each geometric shape.

COPYRIGHT AUTHORIZATION
A portion of the disclosure of this patent document contains material which is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of the patent disclosure, as it appears in the Patent and Trademark Office patent files or records, but otherwise reserves all copyright rights whatsoever.

Craft art product including three-dimensional bead matrix designs


A conductor and a rotating electric high-voltage machine that includes the conductor has a cable configured for high-voltage operation. The cable may be included as a winding for the rotating electric high-voltage machine. The conductor includes a first strand that is clad with an electrically insulating layer, and a second strand that is uninsulated whereas the first strand and the second strand are arranged in two or more layers of strands. The two or more layers of strands are insulated from one another. Furthermore, the first and second layers of the two or more layers of strands are arranged around a central core where the central core is at least one of an air core and a core of another material. The second strand is positioned so as not to be electrically contacting any other uninsulated strand.

1. Field of the Invention
The present invention relates to conductors for high-voltage windings, preferably for high-voltage windings of a stator in a high-voltage generator, which conductors are stranded with two or more layers of strands electrically insulated from each other, around a central core, which core may be one of the strands of the conductor, air or other material.
The invention also relates to rotating electric machine of the type described herein.
The rotating electrical machines referred to in this context are e.g. synchronous machines, but also double-fed machines, applications in asynchronous static current converter cascades, outerpole machines and synchronous flux machines as well as alternating current machines intended primarily as generators in a power station for generating electric power.
Magnetic circuits referred to in this context, include a magnetic core of laminated, non-oriented or oriented, sheet or other material, for example amorphous or powder-based, or any other arrangement for the purpose of allowing an alternating magnetic flux, a winding, a cooling system, etc., and which may be arranged in the stator of the machine, in the rotor or in both.
2. Discussion of the Background
The stator winding in known generators traditionally consists of an electric conductor having a number of insulated rectangular wires, also known as strands, of copper, aluminium or other suitable metal. These strands are transposed (i.e. change place with each other) and are surrounded by a common insulation in such a way that the bundle of conductors acquires a rectangular cross section. The copper conductors are rectangular in order to reduce the eddy-current losses accomplished by keeping (the linear dimension in the direction of the magnetic field small). However, a conductor with rectangular cross section in a high-voltage insulation (i.e. in a conductor) has the disadvantage in that it provides a much greater field strength at the corners of the conductor, the corners thus becoming dimensioning for the thickness of the insulation. Therefore, from the point of view of optimal insulation thickness, circular conductors would be preferable.
Circular conductors can be constructed in a great number of different ways. The conductor may, for instance, consist of the following:
1) a solid rod of copper or other metal with circular cross section,
2) a conductor stranded from circular wires having the same or different diameters,
3) a conductor stranded from sectioned wires or,
4) a conductor compressed from a number of segments, each of which is in turn stranded from circular wires and then formed into a segment.
In order to reduce the conductor dimension it is sometimes compressed or compacted after stranding, thereby altering the shape of the strands in the outermost layer or in the whole conductor, which may costitute a disadvantage.
To ensure high energy transfer in voltage-transmission lines with a conductor for a given voltage, the current must be increased, which is only possible if the conductor area is increased. When the current becomes large this entails the drawback that the current distribution in the conductor becomes uneven (the current endeavours to reach the outer surface of the conductor) and what is known as a xe2x80x9cskin effectxe2x80x9d, current pinch effect, is obtained. To counteract this effect, conductors , according to prior art, having a large cross section ( greater than 1200 mm2 Cu) are produced, usually called Millikan conductors, i.e. conductors built up of a number of concentrically arranged wires which have subsequently been compressed and shaped. Such a conductor is often composed of 5 or 7 segments which are in turn insulated from each other. Such a construction is effective in reducing the current pinch effect in transmission and distribution cables for high-voltage.
It is previously known that, in distribution systems for high-voltage power transmission, all the strands in the cable have been insulated with varnish, for instance, in order to reduce the current pinch effect, see the publication Hitachi Cable Review, No. 11, August 1992, pages 3-6: xe2x80x9cAn EHV Bulk Power Transmission Line Made with Low Loss XLPE Cablexe2x80x9d. This publication also describes how a few of the strands in the outermost layer are left uninsulated in order to prevent differences in potential between the wire strands and the inner semi-conductor layer. No application of this technology on generator windings, however, is described.
With generators having conventionally designed stator windings as described above, the upper limit for generated voltage has been deemed to be 30 kV. This usually means that a generator must be connected to the power network via a transformer which steps up the voltage to the level of the power network, xe2x80x94in the range of 130-400 kV.
During the last decades, there have been increasing demands for rotating electric machines for higher voltages than what has previously been possible to design. The maximum voltage level which, according to the state of the art, has been possible to achieve for synchronous machines with a good yield in the coil production is around 25-30 kV. It is also commonly known that the connection of a synchronous machine/generator to a power network must take place via a xcex94/Y-connected so-called step-up transformer, since the voltage of the power network normally lies at a higher level than the voltage of the rotating electric machine. Thus, this transformer, and the synchronous machine, constitute integral parts of an installation. The transformer constitutes an extra cost and also has the disadvantage that the total efficiency of the system is reduced. If it were possible to manufacture machines for considerably higher voltages, the step-up transformer could thus be omitted.
Attempts to develop the generator for higher voltages have, however, been in progress for a long time. This is clear, for instance from xe2x80x9cElectrical Worldxe2x80x9d, Oct. 15, 1932, pages 524-525, which describes how a generator designed by Parson in 1929 was arranged for 33 kV. It also describes a generator in Langerbrugge, Belgium, which produced a voltage of 36 kV. Although the article also speculates on the possibility of increasing voltage levels still further, the development was curtailed by the concepts upon which these generators were based. This was primarily because of the shortcomings of the insulation system where varnish-impregnated layers of mica oil and paper were used in several separate layers.
Certain attempts to find a new approach as regards the design of synchronous machines are described, inter alia, in an article entitled xe2x80x9cWater-and-oil-cooled Turbogenerator TVM-300xe2x80x9d in J. Elektrotechnika, No. 1, 1970, pp. 6-8, in U.S. Pat. No. 4,429,244 xe2x80x9cStator of Generatorxe2x80x9d and in Russian patent document CCCP Patent 955369.
The water- and oil-cooled synchronous machine described in J. Elektrotechnika is intended for voltages up to 20 kV. The article describes a new insulation system consisting of oil/paper insulation, which makes it possible to immerse the stator completely in oil. The oil can then be used as a coolant while at the same time using it as insulation. To prevent oil in the stator from leaking out towards the rotor, a dielectric oil-separating ring is provided at the internal surface of the core. The stator winding is made from conductors with an oval hollow shape provided with oil and paper insulation. The coil sides with their insulation are secured to the slots, made with rectangular cross section, by way of wedges. As coolant, oil is used both in the hollow conductors and in holes in the stator walls. Such cooling systems, however, entail a large number of connections for both oil and electricity at the coil ends. The thick insulation also entails an increased radius of curvature of the conductors, which in turn results in an increased size of the winding overhang.
The above-mentioned U.S. patent relates to the stator part of a synchronous machine which comprises a magnetic core of laminated sheet with trapezoidal slots for the stator winding. The slots are tapered since the need of insulation of the stator winding is smaller towards the interior of the rotor where that part of the winding which is located nearest the neutral point is disposed. In addition, the stator part comprises a dielectric oil-separating cylinder or ring nearest the inner surface of the core which may increase the magnetization requirement relative to a machine without this ring. The stator winding is made of oil-immersed cables with the same diameter for each coil layer. The layers are separated from each other by way of spacers in the slots and secured by wedges. What is special for the winding is that it comprises two so-called half-windings connected in series. One of the two half-windings is disposed, centered, inside an insulation sleeve. The conductors of the stator winding are cooled by surrounding oil. The disadvantage with such a large quantity of oil in the system is the risk of leakage and the considerable amount of cleaning work which may result from a fault condition. Those parts of the insulation sleeve which are located outside the slots have a cylindrical part and a conical termination reinforced with current-carrying layers, the purpose of which is to control the electric field strength in the region where the cable enters the end winding.
From CCCP 955369 it is clear, in another attempt to raise the rated voltage of the synchronous machine, that the oil-cooled stator winding comprises a conventional insulated conductor for medium voltage with the same dimension for all the layers. The conductor is placed in stator slots formed as circular, radially disposed openings corresponding to the cross-section area of the cable and with the necessary space for fixation and for coolant. The different radially disposed layers of the winding are surrounded by and fixed in insulated tubes. Insulating spacers fix the tubes in the stator slot. Because of the oil cooling, an internal dielectric ring is also needed here for sealing the coolant against the internal air gap. The design shown has no tapering of the insulation or of the stator slots. The design exhibits a very narrow radial waist between the different stator slots, which means a large slot leakage flux which significantly influences the magnetization requirement of the machine.
In a report from the Electric Power Research Institute, EPRI, EL-3391 from April 1984, an account is given of generator concepts for achieving higher voltage in an electric generator with the object being to connect such a generator to a power network without intermediate transformers. Such a solution is assessed in the report to offer good gains in efficiency and considerable financial advantages. The main reason that it was deemed possible in 1984 to start developing generators for direct connection to power networks was that a super-conducting rotor had been developed at that time. The considerable excitation capacity of the super-conducting field enables the use of an airgap-winding with sufficient thickness to withstand the electrical stresses.
By combining the concept deemed most promising according to the project, that of designing a magnetic circuit with a winding, known as a xe2x80x9cmonolith cylinder armaturexe2x80x9d, a concept in which two cylinders of conductors are enclosed in three cylinders of insulation and the whole structure is attached to an iron core without teeth, it was assessed that a rotating electric machine for high-voltage could be directly connected to a power network. The solution entailed the main insulation having to be made sufficiently thick to withstand network-to-network and network-to-ground potentials. Drawbacks with the proposed solution, besides its demand for a super-conducting rotor, are that it also requires extremely thick insulation, which increases the machine size. The coil ends must be insulated and cooled with oil or freons in order to control the large electric fields at the ends. The whole machine must be hermetically enclosed in order to prevent the liquid dielectric medium from absorbing moisture from the atmosphere.
The object of the present invention is to solve the above mentioned problems and to provide a rotating electric machine which permits direct connection to all types of high-voltage power networks.
This object is achieved by providing a conductor for high-voltage windings, as described herein with the advantageous features also described herein. A feature of the invention is that the electrical insulation between the strands of the conductor is made such that only certain strands are clad with an electrically insulating layer, and these strands which are provided with the insulating layer are so situated within the layers of the conductor that no two uninsulated strands come into electrical contact with each other.
Preferably, the electric conductor according to the invention has a number of twisted layers consisting of strands, of copper, aluminium or other suitable metal. However, contrary to conventional conductors for power transmission, the electrically conducting layer of the conductor is subjected to a magnetic field which induces currents, resulting in losses. In order to reduce these losses, therefore, the strands must be insulated from each other, but the requirement still remains that at least some strand in the outermost layer must be in contact with an inner semiconducting layer in the conductor""s insulation. Therefore, the conductor is further characterized in that at least one strand in the outermost strand layer is uninsulated.
The uninsulated strand or strands in the outer layer of the conductor defines the potential on the inner semiconducting layer and thereby the advantage is achieved that it ensures a uniform electric field within the insulation. By using uninsulated strands instead of insulated strands the advantage is also achieved of obtaining a less expensive insulated conductor for a winding.
As yet another advantageous feature the present invention, only a minority of said strands are uninsulated from each other.
As regards the rotating electric machine according to the present invention, it is characterized in that the winding has at least one current-carrying conductor that a first layer having semiconducting properties is provided around said conductor, that a solid insulating layer is provided around said first layer, and that a second layer having semiconducting properties is provided around the insulating layer.
Preferably, a rotating electric machine according to the present invention has a high-voltage insulated conductor/cable with a central electric conductor. Also the machine has a number of strands of copper (Cu), for instance, usually having a circular cross section. These strands are arranged in the middle of the high-voltage cable. Around the strands is a first semiconducting layer, and around the first semiconducting layer is an insulating layer, e.g. crosslinked polyethylene (XLPE) insulation. Around the insulating layer is a second semiconducting layer. Thus, in the present case, the concept of a xe2x80x9chigh-voltage cablexe2x80x9d normally used to denote a winding in a rotating electric machine does not include the outer protective sheath that normally surrounds such cables for power distribution. Furthermore, in a high-voltage cable for power distribution there is also an outer insulating layer on top of the second semiconducting layer, which is not included here.
By using conductors, of substantially the same type as conductors for transferring electric power, in the stator winding of the generator, in accordance with the invention, the advantage is achieved that the voltage of the machine is increased to such a level that it can be connected directly to the power network without intermediate transformers.
A rotating electric machine as described herein makes it is possible to have at least one winding system of conductors suitable for direct connection to distribution or transmission networks.
This also entails the further important advantage that the xcex94/Y-connected step-up transformer mentioned above can be omitted. Consequently, the solution according to the present invention represents major savings both in economic terms and regarding space requirement and weight for generator plants and other installations that use rotating electric machines.
To be able to cope with the problems which arise in case of direct connection of rotating electric machines to all types of high-voltage power networks, a machine according to the present invention may have a number of features which significantly distinguishes it from the state of the art both as regards to conventional mechanical engineering and the mechanical engineering which has been published during the last few years, some of which will follow below.
As mentioned, the winding is manufactured from one or more insulated conductors with an inner and an outer semiconducting layer, preferably an extruded cable of some sort. Some typical examples of such conductors are a cable of crosslinked polyethylene (XLPE) or a cable with ethylene propylene (EP) rubber insulation, which, however, for this purpose and according to the invention, has an improved design both as regards the strands of the conductor and as regards the outer layer.
The conductor is provided with an outer semiconducting layer with the aid of which its potential in relation to the surroundings shall be defined. This layer must therefore be connected to ground, at least somewhere in the machine, possibly only in the coil-end section.
The use of an insulated conductor with an outer semiconducting layer has the advantage that it permits the outer layer of the winding, in its full length, to be maintained at ground potential. Consequently, the invention may have the feature that the outer semiconducting layer is connected to ground potential. As an alternative, the outer layer may be cut off, at suitable locations along the length of the conductor, and each cut-off part length may be directly connected to ground potential.
A considerable advantage with having the outer layer connected to ground potential is that the electric field will be near zero in the coil-end region outside the outer semiconductor and that the electric field need not be controlled. This means that no field concentrations can be obtained, neither within the sheet, nor in the coil-end region, nor in the transition therebetween.
As another advantageous feature, at least two, and preferably all three, of the layers have substantially equal thermal expansion coefficients. Through this it is achieved that thermal movement is prevented and the occurrence of cracks, fissures or other defects in the winding due to thermal movement is avoided.
According to another characterizing feature each of the three layers is solidly connected to the adjacent layer along substantially the whole connecting surface. This has the advantage that the layers are fixed and unable to move in relation to each other and serves to ensure that no play occurs between the layers. It is very important that no air is allowed to enter in-between the layers since that would lead to disturbances in the electric field.
As mentioned, the present invention is intended for use at high voltages, which here refers primarily to voltages in excess of 10 kV. A typical operating range for a device according to the invention may be voltages from 36 kV up to 800 kV, preferably in the range 72,5-800 kV. In addition, the invention has the advantage to ensure uniform current distribution, counteract eddy-current losses and ensure that the inner semiconducting layer of the insulation system has the same potential during operation as the wire or strand layers in the conductor.
The material requirements for the insulating layer with regard to the XLPE process, for instance, are that it shall be stable, will not melt and is resistant to deformation at temperatures up to 220xc2x0 C. for approximately 30 min. Examples are enamelled wire, powder sintering (epoxy, high-temperature plastic), extruded high-temperature plastic, and oxide layers.
The above-mentioned object of the present invention is optimized by the various embodiments of the construction of the conductor as discussed herein.

Conductor for high-voltage windings and a rotating electric machine comprising a winding including the conductor